Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

NCT03771274 | Completed Results FDA Device

• 1 other identifier: CEP18-002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.

Conditions

Cataract Bilateral; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Binocular Uncorrected Near (40 cm) Visual Acuity.

  Visual acuity measured at 40 cm without wearing any correction.

  3 months

Secondary Outcomes (3)

• Patient Visual Satisfaction After Cataract Surgery: Questionnaire

  3 months

• Spectacle Independence: Questionnaire

  3 months

• Number of Participants With Visual Symptoms

  3 months

Study Arms (1)

Tecnis ZLB00 & Symfony IOL

EXPERIMENTAL

The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.

Device: Tecnis ZLB00 & Symfony IOL

Interventions

Tecnis ZLB00 & Symfony IOL DEVICE

The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.

Tecnis ZLB00 & Symfony IOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
• Willing and able to provide written informed consent for participation in the study
• Willing and able to comply with scheduled visits and other study procedures.
• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
• Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if:

• Contraindication for a presbyopia correcting IOL.
• Subjects with severe astigmatism in the non-dominant eye
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• Clinically significant corneal dystrophy
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous intraocular surgery.
• Previous refractive surgery.
• Previous keratoplasty
• Severe dry eye
• Pupil abnormalities

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Director of Research
• Organization: Carolina Eyecare Physicians, LLC

helga.sandoval@carolinaeyecare.com

8438813937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: December 7, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: August 10, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)